Evaluation of Levemir® for the Treatment of Type 1 and 2 Diabetes

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: insulin detemir

• Registration Number: NCT00655044
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using Levemir® under normal clinical practice conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-08
• Study First Posted: 2008-04-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3637

Inclusion Criteria

• Type 1 diabetes
• Type 2 diabetes
• Candidates of use of a basal insulin as part of their diabetes regimen

Exclusion Criteria

• Unwilling to adhere to therapy or follow up
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 1 and type 2 diabetes patients	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
HbA1C	after 12 weeks

Secondary Outcome Measures

Name	Time	Method
Safety	during treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇷🇺 Moscow, Russian Federation